Project Engineer III

eTeam; Fremont (CA); On-site; USD 110,000 - 170,000; Full time

Job summary

eTeam is seeking a Project Engineer III in Fremont, CA for a 6-month assignment. The role serves as the engineering technical lead for Bulk Drug Substance, Drug Product and/or Process Science systems, owning equipment like bioreactors, CIP/SIP, and filling/packaging lines.

Responsibilities include leading CAPEX/OPEX/CI projects, risk assessments, change control, deviation management and startup/commissioning activities.

Qualifications

• Minimum 4 years’ working experience in a GMP manufacturing environment.
• Expert troubleshooting of process equipment and systems.
• Proven project leadership in CAPEX/OPEX or CI initiatives.
• Strong written and verbal communication skills.
• Ability to own risk assessments and deviation investigations.

Responsibilities

• Lead/participate in CAPEX/OPEX/CI projects from feasibility to handover.
• Own risk assessment for new systems and changes to existing systems.
• Lead startup/commissioning activities and approve SOPs.
• Act as technical approver of protocols and monitoring activities.
• Oversee contractors and provide guidance/approval on activities on site.
• Ensure compliance with GMP, quality and EHS standards.

Skills

GMP compliance

Process equipment

Troubleshooting

Project leadership

CAPA & change control

Risk assessment

Documentation

Contract management

Job description

Job Title: Project Engineer IIIDuration: 6 monthsLocation: Fremont, CA

Duties:The Senior Engineer, Equipment is the Engineering technical lead on the Bulk Drug Substance (BDS), Drug Product (DP) and/or Process Science (PS) systems.The Senior Engineer is responsible for Upstream and Downstream BDS, Filling and Packaging equipment.Serve as a primary consultant to troubleshoot equipment/process issues through initial qualification and system release, support/participate/lead site CAPEX/OPEX/continuous improvement projects from feasibility study to handover.Might also own change control and participate in deviation/risk assessment activities.Manage medium in size and complexity equipment related projects.Expected to act as System Owner for Process equipment (out of tolerance events, deviations, etc.) if required by area.Technical ExpertiseExperience and knowledge with process systems and equipment within the following areas: Bioreactors, Centrifuges, Chromatography skids and Columns, Prep and Hold tanks, CIP/SIP, Filling and Packaging equipmentUses expert knowledge about the processes, automation and process-specific technology to participate in troubleshooting as the Engineering technical lead.Technical Analysis: including process system and technology plant fits, capacity and equipment utilization, value engineering, sustainable design, constructability and assessment of applicable new technologies to balance performance, cost and maintainability.

Project ManagementLead/participate in CAPEX/OPEX/CI projectsOwn risk assessment for new systems and changes to existing systemsWrite/review project execution plansLead/manage startup/commissioning activities (e.g. approve commissioning report, review/approve TOPs, create/update/review/approve SOPs...)Technical approvers of protocols and periodic monitoringLead/manage project team including overseeing & providing guidance on contractors’ activitiesProvides estimates of resource requirements

Optimization & ComplianceOwn technical optimization of the field of care.Leads the facility equipment, machinery, documentation and technical support meet the compliance, quality and EHS standards.Leads/motivates activities to ensure a continuous optimization process.Leads/execute CAPA, deviation, change control, and risk assessment (quality, business and/or safety)

Global EngineeringLeads implementation and improvement of best practice of technical standards, procedures.Aracts as a member of Global Engineering Biopharmaceuticals and of global Engineering Client.Participates in peer-to-peer reviews as needed.Regulatory and/or Organizational Requirements:
Regulatory requirement per GMP, OSHA and FDAPhysical demands/surroundings - work primarily in an office environment. Required to be on the process floor as necessary to perform work outlined in this profile.Some domestic and international travel may be required.Visual Demands - must be able to read and see clearly with or without correction lenses.Attendance/schedule - attendance requirements are based on general attendance policies and the needs of the business as set forth by direct manager.

Job Complexity:Capable to balance conflicting priorities and agile to manage changing prioritiesAbility to establish highly functional relationships with diverse personalitiesInternal cross functional groups - Mfg, SCM, Quality, CMO, Finance, ITExternal contingency worker, contractors, possible customers, auditor

Skills:Knowledge of GMP complianceTechnical expertise on process equipment/systemRecognize safety requirements in manufacturing environmentEquipment hands on experienceProject leadership experienceMinimum of 4 years’ working experience in a GMP manufacturing environmentExcellent oral and written communication skillsMinimum 5 years and hands on experience with process system/equipmentCapable to own and lead risk assessment, root cause investigation, project startup/commissioning/qualification.Expert on troubleshooting technical issuesOwner of change control, deviation and CAPACapable to lead projects (CAPEX or CI)Oversee contractor(s) and provide guidance/approval on activities at site